Anita Simkins

Anita has a combination of 23 years of experience working within CLIA, ISO, GMP, GLP and GCP environments within pharmaceutical, diagnostic, biotechnology and Clinical Research Organizations. She has developed and implemented Quality Management Systems in compliance with US/EU regulations and has had extensive Quality Assurance GxP experience in regard to the manufacturing of vaccines and small molecules, and bioanalytical analysis. As a Quality Assurance Manager at previous companies (BioCryst, AlphaVax and Trimeris), Anita provided leadership and direction to ensure critical quality points were identified and monitored. She also has worked at two CROs, Kendle and Quintiles, as a clinical auditor, and at GlaxoSmithKline, where she provided practical and theoretical expertise for the development and validation of Immunogenicity testing.

Anita has a BS in Clinical Laboratory Science from East Carolina University and maintains two certifications: American Society of Clinical Pathology and Register Quality Assurance Professional- GLP. She is also a member of the Society of Quality Assurance and currently a Director of Issues and Methods on the North Carolina Chapter of the Society of Quality Assurance.